Redefining quality in cell and gene therapies: Lessons from implementing electronic QMS in academic cGMP facility

Manufacturing cell and gene therapies (CGTs) involves complex processes that require robust quality management, especially within academic current Good Manufacturing Practice (cGMP) facilities, where resources are often limited. Traditional paper-based quality management systems (QMSs), while initially convenient, often become burdensome, leading to errors, poor traceability, and compliance risks. Electronic QMSs (eQMSs) are gaining recognition for their ability to centralize and automate key quality processes, significantly enhancing operational efficiency and regulatory readiness. Through an in-depth case study of the University of Southern California and Children's Hospital of Los Angeles academic cGMP facility, this review demonstrates tangible improvements achieved by adopting an eQMS. Practical insights gained from this experience are shared, including careful selection of eQMS platforms, phased rollout strategies, and comprehensive staff training. The review also addresses common implementation challenges and suggests practical solutions to overcome them. Lessons learned and strategies discussed here can serve as valuable guidance for other academic institutions considering eQMS adoption. Ultimately, embracing an eQMS enables academic CGT manufacturers to operate more efficiently and stay ahead in a fast-moving field.